Phase 2a Study of MN-16 in Opioid Abusers

MediciNova Inc. has announced the initiation of enrollment of a Phase 2a clinical trial with MN-166 (ibudilast) in prescription opioid or heroin abusers. The trial will be conducted at Columbia University and the New York State Psychiatric Institute and is funded by the National Institutes for Drug Abuse (NIDA), part of the National Institutes of Health.

The MN-166 Phase 2a trial signifies the next step in the development of MN-166 and is the second of a strategic set of trials assessing the potential for MN-166 in opioid abuse and withdrawal. MN-166 is also in a Phase 2 trial for methamphetamine addiction at the University of California, Los Angeles and will soon begin a separate Phase 2 trial for patients with multiple sclerosis.

The NIDA-supported trial will enroll 24 healthy abusers of prescription opioids (including OxyContin, Vicodin, and Percocet) or heroin. The goal of the trial is to assess MN-166's ability to not only reduce withdrawal symptoms following opioid detoxification, but to reduce the tendency to self-administer oxycodone, a frequently prescribed and abused opioid, and improve the acute pain relief action of oxycodone. The clinical trial subjects will complete two 20-day periods in a clinical research unit wherein they are detoxified and randomized to placebo or 100mg/day ibudilast (MN-166).

MN-166 is an orally bioavailable small molecule glial attenuator. It suppresses pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10 and neurotrophic factors like GDNF. While considered a New Molecular Entity in the United States and Europe, the therapy was first approved in Japan more than 15 years ago. The drug has been prescribed in Japan to over one million patients for asthma and post-stroke complications.